Table 2.
Adverse Events (Safety Analysis Population)
| Adverse Events [n (%)] | Modal 40 mg Group (N=153) | Modal 80 mg Group (N=136) |
|---|---|---|
| Any adverse events | 71 (46.4) | 75 (55.1) |
| Common adverse eventsa | ||
| Akathisia | 14 (9.2) | 5 (3.7) |
| Nasopharyngitis | 7 (4.6) | 10 (7.4) |
| Schizophrenia | 9 (5.9) | 7 (5.1) |
| Insomnia | 6 (3.9) | 7 (5.1) |
| Nausea | 7 (4.6) | 5 (3.7) |
| Blood prolactin increased | 4 (2.6) | 7 (5.1) |
| Constipation | 3 (2.0) | 8 (5.9) |
| Headache | 3 (2.0) | 8 (5.9) |
| Anxiety | 4 (2.6) | 5 (3.7) |
| Back pain | 2 (1.3) | 4 (2.9) |
| Cough | 2 (1.3) | 4 (2.9) |
| Parkinsonism | 3 (2.0) | 3 (2.2) |
Notes: a≥2% in safety analysis population. Modal 40 mg group: Subjects who received 40 mg for most days during the extension phase. Modal 80 mg group: Subjects who received 80 mg for most days during the extension phase.